Download FreedomEdge™ Instructions For Use - Repro

Instructions For Use
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
FreedomEdge™ Pump Diagram . . . . . . . . . . . . . . . . . . . . 4
FreedomEdge™ Product Listing . . . . . . . . . . . . . . . . . . . . 4
Syringes for Use with FreedomEdge™ . . . . . . . . . . . . . . 5
Testing FreedomEdge™ Pump . . . . . . . . . . . . . . . . . . . . . 5
Syringe Loading and Removal Instructions . . . . . . . . 6
Selected Flow Rates vs Time . . . . . . . . . . . . . . . . . . . . . . . . 7
Starting the Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pausing and Checking Infusion Progress . . . . . . . . . . . 8
End of Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Care and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FreedomEdge™ Flow Profile . . . . . . . . . . . . . . . . . . . . . . . . 11
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Definition of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
English 1 of 16
Introduction:
The FreedomEdge™ Syringe Infusion System is portable and easy to use, requiring
no batteries or electricity. It starts to operate when the pump is closed. RMS Precision
Flow Rate Tubing™ sets are used to control the flow rate.
The FreedomEdge™ operates at a constant safe pressure of 13.5psi. The constant
pressure developed in the FreedomEdge™ automatically decreases the flow rate if
there is an increase in resistance during the delivery. The system will find equilibrium
between the increasing resistance and flow rate. It provides constant flow which
tends to inhibit clots, and holds full pressure after an infusion is complete to prevent
blood or drug backflow. The FreedomEdge™ also eliminates concerns of a bolus,
overflow, overdose, or runaway infusion.
The FreedomEdge™ offers all the performance and technology of the FREEDOM60®,
in a design for 20ml and 30ml syringes. The FREEDOM60® is designed for
60ml syringes.
Indications for Use:
The FreedomEdge™ Syringe Infusion System is indicated for the infusion of prescribed
liquid medicines.
Contraindications:
The FreedomEdge™ is not intended for the delivery of blood, critical* or life-sustaining
medications, or for the infusion of insulin.
*Critical may be defined as medication requiring greater accuracy of delivery, such as CNS opiate
depressants which in certain countries, e.g. UK, may be limited by local regulations. CONSULT
LOCAL REGULATORY AUTHORITIES.
English 2 of 16
Caution:
• Use the FreedomEdge™ Syringe Infusion System only for the patient for whom the
device is prescribed and only for its intended use.
• Do not connect an extension tubing or needle set directly to the syringe. An appropriate flow restrictive tubing with a disc luer is required for use with the FreedomEdge™.
• Use only recommended syringes with the FreedomEdge™.
• Do not use syringes smaller than 20ml. The use of a smaller syringe may cause high
pressures that can be unsafe for the patient.
• Using the same tubing set, 30ml syringes will have different flow rates and delivery
times versus 20ml syringes.
• Before use, carefully inspect the tubing set package. Do not use the tubing set if the
package is opened or damaged.
• Do not re-sterilize tubing sets.
• Overuse of the slide clamp or storing tubing sets with the slide clamp engaged for long
periods of time* may damage the tubing and affect the infusion rate.
• Carefully inspect the FreedomEdge™ Syringe Infusion Pump before use. Verify its condition and test. If the pump is believed to not be operating properly or at the appropriate
rate of flow, immediately discontinue use.
• The FreedomEdge™ Syringe Infusion System does not have an alarm, therefore no alarm
will sound if an interruption to flow occurs. There is no display of infusion status. The
pump is not suitable for use with medication where delay or under-infusion could result
in serious injury.
• Discontinue use of a pump that has been damaged, exposed to severe impact, or which
has failed to test properly.
• Discontinue use of a pump that has been submerged in fluid. If any fluid is allowed
to enter the pump, other than moisture from cleaning or sanitizing, it should be
replaced immediately.
• Do not autoclave the FreedomEdge™. It will melt the plastic and damage the pump.
• Federal law (USA) restricts this device to sale by or on order of a physician.
• Tubing that is pre-primed and shipped at temperatures below freezing could
be damaged.
*Generally greater than 2 hours.
English 3 of 16
FreedomEdge™ Pump Diagram:
PROGRESS
WINDOW
closed
extended
PUMP NOSE
FRONT LIP
fully extended
and open
LUER
CRADLE
SYRINGE
LOCATOR
SYRINGE
PUSHER
ARMS
Product Listing:
Each FreedomEdge™ Syringe Infusion System
includes a carrying pouch and user manual.
Product
FreedomEdge™ Syringe Infusion Pump
FreedomEdge™ Carrying Pouch
Part #
F10020
347400
RMS Precision Flow Rate Tubing™ (case of 50)
Part #
F0.5
F1
F2
F3
F3.8
F5
F8
F10
F15
F30
F45
Flow Rate*
0.5ml/hr1
1ml/hr1
2ml/hr1
3ml/hr1
3.8ml/hr1
5ml/hr1
8ml/hr1
10ml/hr1
15ml/hr1
30ml/hr2
45ml/hr2
Part #
F60
F120
F180
F275
F420
F500
F600
F900
F1200
F2400
Flow Rate*
60ml/hr2
120ml/hr2
180ml/hr3
275ml/hr3
420ml/hr3
500ml/hr3
600ml/hr3
900ml/hr3
1200ml/hr3
2400ml/hr3
END CAP
LUER DISC
END CAP
SLIDE CLAMP
with PART #
* Flow rates will be approx. 76% of this number with a 30ml syringe.
1 Sterile water for injection (SWFI) direct flow rates valid with select 20mL syringes.
2 Adjusted for antibiotic use, for actual flow rates see examples on pages 10-11.
3 Typically used for viscous drugs, SWFI flow rates will be reduced from stated values.
English 4 of 16
For Larger Volume Infusions:
The FreedomEdge™ offers all the performance and technology of the FREEDOM60®,
in a design for 20ml and 30ml syringes. For larger volumes, the FREEDOM60®
accommodates 60ml syringes.
Part #: F10050
Syringes For Use with the FreedomEdge™:
• Becton Dickinson & Co. BD® Luer-Lok™ 20ml (US Reference numbers: 302830
and 301031)
• Becton Dickinson & Co. BD® Luer-Lok™ 30ml (US Reference number: 301033)
Testing the FreedomEdge™ Syringe Infusion Pump:
1. Examine the inside to ensure it is free of debris or contamination.
2. Test to make sure the syringe locator moves freely by sliding it up
and down with your finger.
Note: For bench testing of flow accuracy refer to page 10. Note that the negator
mechanism which drives the syringe is calibrated for the life of the pump. RMS
Precision Flow Rate Tubing™ sets are always measured to flow specification during
manufacture and will deliver the appropriate flow rate under controlled conditions.
English 5 of 16
Syringe Loading and Removal Instructions:
To load a syringe:
syringe
locator
syringe flange
1.
2.
3.
4.
5.
Pull firmly to fully extend the pump.
Then, open the pump fully by lifting the top cover.
With syringe gradations facing up, push the syringe against the syringe locator.
Seat the syringe flange into the syringe locator.
Seat the luer disc inside the pump nose so that the syringe is firmly attached
inside the pump.
Note: You can test proper fit by gently tugging on the syringe. It will stay in place
if properly attached.
To remove a syringe:
After the infusion is complete, open the pump.
1. Remove the empty syringe by gently pushing it back to disengage the nose.
2. Lift the syringe up out of the pump.
Note: You will never need to use force to load or remove a syringe.
English 6 of 16
Selected Flow Rates vs Time:
Note: For assistance in determining which Precision Flow Rate Tubing™ set to
use, please contact RMS Medical Products at 800-624-9600.
Flow Rate vs Time Chart:
Syringe
Volume 1ml/hr
2ml/hr
30ml/hr
45ml/hr
60ml/hr
120ml/hr
5ml
5 hrs.
2 hrs. 30 min.
10 min.
6 min. 42 sec.
5 min.
2 min. 30 sec.
10ml
10 hrs.
5 hrs.
20 min.
13 min. 18 sec.
10 min.
5 min.
15ml
15 hrs.
7 hrs. 30 min.
30 min.
20 min.
15 min.
7 min. 30 sec.
20ml
20 hrs.
10 hrs.
40 min.
26 min. 42 sec.
20 min.
10 min.
25ml
25 hrs.
12 hrs. 30 min.
50 min.
33 min. 18 sec.
25 min.
12 min. 30 sec.
30ml
30 hrs.
15 hrs.
60 min.
40 min.
30 min.
15 min.
Note: Tubing that is pre-primed for and shipped at temperatures below freezing
could be damaged.
Starting the Infusion:
1. Verify that you have the correct RMS Precision Flow
Rate Tubing™ set.
2. Using sterile technique, remove the cap from the
luer disc end of the tubing set and connect the
tubing to the pre-filled syringe. Make sure tubing
is appropriately primed, ensuring air has been removed.
3. Load syringe. Follow syringe loading instructions
from page 6. Make sure the luer disc is fully seated
in the pump’s nose.
Note: You will never need to use force to load or
remove a syringe.
4. Remove the cap from the other end of the tubing
and connect the tubing to the patient’s indwelling
needle or catheter.
5. Begin the infusion by closing the pump lid. The
infusion begins immediately. To pause the infusion
at any time, fully open the pump.
English 7 of 16
Pausing the Infusion:
To stop the flow, fully open the lid to relieve pressure from the syringe plunger.
Resume by fully closing the lid again.
Checking Infusion Progress:
Check infusion progress by taking note of the time the infusion started and
periodically checking the elapsed time against the movement of the syringe plunger,
as seen through the progress window. With 20ml syringes, the approximate rate for
antibiotics or other non-viscous solutions can be found on the slide clamp attached
to the tubing. (i.e., F60 will flow at 60ml/hr, F30 will flow at 30ml/hr, etc.). 30ml
syringes will flow at 76% of the flow rate of 20ml syringes. To correct for this, multiply
the 20ml flow rate by .76 for 30ml syringes.
For example: With saline, F120 tubing will flow 120ml/hr with 20ml syringes.
After multiplying, the flow rate is 91.2ml/hr with a 30ml syringe.
End of Infusion:
1.
2.
3.
4.
Confirm that the syringe is empty.
Open the pump by lifting up the top cover.
If not attaching another syringe, disconnect the tubing from the patient.
Gently remove the syringe as described on page 6.
Note: If the dose is greater than 20ml/30ml and an additional syringe is required,
load the additional syringe by repeating section titled, ‘Starting the Infusion’.
Troubleshooting:
If the suggestions in this section do not solve your problem, or
if problems persist, discontinue use and consult RMS Medical
Products and/or your healthcare provider.
Syringe will not load or remove from pump
Note: You will never need to use force to load or
remove a syringe.
1. Make sure the is pump fully open, and that nothing is
blocking the syringe locator.
2. Confirm you are not filling the syringe to more than
30ml, or using a syringe larger than 30ml.
3. If you still have difficulty, use one hand to slide the
syringe locator all the way back, then place the syringe.
fully open
Syringe will not stay inside in the pump
1. Make sure you are using the RMS Precision Flow Rate
Tubing™ sets with the luer disc and the RMS tag.
2. Make sure the luer disc end of the tubing has been
connected to an approved syringe and that the disc
is seated properly inside the nose of the pump.
3. Make sure the flange shape of the syringe is correctly
seated into the shape of the syringe locator.
English 8 of 16
Syringe will not stay inside in the pump (continued)
3. Make sure the flange shape of the syringe is
correctly seated into the shape of the syringe
locator.
syringe
locator
No flow
• Open and close the lid to ensure the syringe pusher
syringe flange
slides freely and does not bind.
• Make sure the slide clamp is unclamped and has not been used for an extensive
period of time. If the slide clamp is overused it can damage the tubing.
• Test the tubing: Use sterile procedures to disconnect where the indwelling
needle or catheter is connected to the rate controlled tubing set; check for
medication drip. If medication does not drip, replace the tubing as it may be
blocked or damaged. If medication does drip from the Precision Flow Rate
Tubing™, then it is most likely a problem with the indwelling needle, catheter,
or any fluid path accessories such as a clave connector or needle-free adapter.
Slow flow
• Verify that you are using the proper tubing.
• Verify that you are using the proper syringe. 30ml syringes will flow approx
76% of the rate of a 20ml syringe (e.g. 120ml/hr tubing will flow at approx.
91.2ml/hr).
• If a slide clamp is used for an extensive period of time, it can damage the tubing
and affect the flow rate. Try using another tubing set and measure the flow. For
60ml/hr tubing, the syringe plunger should move 10ml in 10 minutes (1ml/min).
For 120ml/hr tubing, the plunger should move 10ml in 5 minutes (2ml/min).
Stopping the flow quickly
• The pump is designed to maintain pressure during and after the infusion to
prevent blood/drug backflow.
• To stop the flow, fully open the lid to relieve pressure from the syringe plunger.
• You can also use the slide clamp. Only use the slide clamp in the case of an
emergency, or when necessary to immediately stop the flow. Overuse can
damage the tubing.
Care and Maintenance:
The FreedomEdge™ does not require any preventative maintenance. The
FreedomEdge™ with RMS Precision Flow Rate Tubing™ works as a system, which means
the tubing determines the flow rate, not the pump; therefore your pump needs no
calibration. Selecting the appropriate tubing set for the application ensures the proper
flow rate will be achieved. During manufacture, Precision Flow Rate Tubing™ sets are
thoroughly quality-tested to high standards, to guarantee flow rate accuracy and
appropriate flow rate delivery under controlled conditions.
Cleaning
Clean only those areas that are exposed and external. No attempt should be made
to clean any part of the pump that is not easily accessible.
English 9 of 16
Wipe the outside surface with warm water and detergent or use any surface
disinfectant compatible with acetyl-butyl-styrene (ABS) plastic, such as hydrogen
peroxide. Avoid the use of alcohol or alcohol-containing compounds, as these tend
to make ABS plastic brittle. Wipe again with clean water to rinse.
If necessary, you may clean the inside of the pump with a damp cloth and any
cleaning agent compatible with ABS plastic.
Storage:
The FreedomEdge™ syringe infusion pump is recommended to be stored in a cool, dry
place. Packaged tubing sets should be stored at room temperature (approximately
16-30°C or 61-86°F).
Testing Flow Accuracy (if required by your local protocol):
1. Completely fill a new BD® 20ml syringe with sterile water. Do NOT use a 30ml
syringe for this test.
2. Remove all air from the syringe.
3. Attach a sterile Precision Flow Rate Tubing™ set to the syringe.
4. Remove all air from the tubing set.
5. Load the syringe into the pump and close the lid fully.
6. Monitor the syringe readings and elapsed time to derive an approximate
flow rate.
7. Compare your test results to the range of test rates listed in the table below:
Labeled Flow Rate
Bench-Rated Flow Rate
Test Range
F60 (60ml/hr)
F120 (120ml/hr)
72ml/hr
134ml/hr
60-84ml/hr
115-153ml/hr
7a. Bench-Rated Flow Rate: The FreedomEdge™ syringe infusion pump design accounts for
the effects of standard clinical conditions on flow rate performance. Under bench test
conditions, a 60ml/hr labeled tubing set is designed to generate a nominal infusion rate of
72ml/hr. A 120ml/hr labeled tubing set will generate a nominal bench test rate of 134ml/hr. The
FreedomEdge™ generates nominal bench test rates higher than the labeled rate accounting for
the following standardized application criteria that affects actual delivery rates under normal
clinical circumstances.
F60 (60ml/hr) Tubing F120 (120ml/hr) Tubing
72ml/hr
134ml/hr
Less Clinical Effects
- 7ml/hr
- 8ml/hr
Catheter Gauge (20G PICC)
Fluid Viscosity
-2ml/hr
-3ml/hr
Venous Pressure
-3ml/hr
-3ml/hr
Label Flow Rate
60ml/hr
120ml/hr
Bench Test Rate
7b. Test Range: To assure consistent test results, keep pump and tubing at the same
approximate horizontal plane and monitor flow until syringe empties (approximately 9 minutes
for F120 or 18 minutes for F60). The FreedomEdge™ system is factory rated to deliver infusions
under strict test conditions over a large number of pumps tested within 7% of nominal with a
95% statistical confidence interval. Under varying bench test and fluid conditions this range
can be expected to vary approximately 15% of nominal. For more accurate monitoring, use a
stopwatch and finely graduated burette. FreedomEdge™ pump testing is based on ANSI/AAMI
National Standard, ID 26-1992, Infusion Devices, August 24, 1992.
English 10 of 16
If test results in the range indicated cannot be approximated under bench testing
conditions, contact RMS Medical Products at 1-800-624-9600.
References:
1. Stuhmeier, Mainzer B. MD; Aspects of pressure build-up in the use of electronic
infusion devices. II. Need for a pressure limit. Anasth Intensivther Notfallmed
(1987 Aug.) 22(4): 185-190.
2. Anasth Intensivther Notfallmed (1987 Aug.) 22(4): 181-184. ANSI/AAMI
National Standard, ID 26-1992, Infusion Devices, August 24, 1992.
FreedomEdge™ Flow Profile:
The FreedomEdge™ flow profile shows that the flow rate is consistent throughout the
delivery of medication.
FreedomEdge™ Flow Rate vs. Time
Fluid: H20 · Fluid Volume: 20ml · Tubing Measured: F60, nominal 72ml/hr
140
Flow Rate (ml/hr)
120
100
80
60
40
20
0
0
100
200
300
400
500
600
700
Time (seconds)
English 11 of 16
Technical Specifications:
System
Reservoir volume:
Residual volume:
Flow rate accuracy:
Operating pressure:
(20ml reservoir)
Height sensitivity:
20ml /30ml
<0.4ml
± 7%*
15psi (peak) 13.5psi (nominal)
± 3% per 12” (30cm)
* Flow rate data recorded at 21°C using 20ml of 0.9% NS. An overall accuracy of ±7%
is expected at these values. At higher temperatures, which results in a decrease in
viscosity, a higher flow rate is anticipated to occur. The flow rate variation due to
changes in temperature is approximately linear and would vary from -20% at 14°C to
+20% at 30°C. Fluids considerably more viscous than 0.9% NS are expected to slow the
flow rate and consequently may result in longer infusion times. More viscous fluids
may be tested before patient use by following the bench test procedures described
in this manual.
Pump
Weight:
Length:
Width:
Height:
12oz (0.34kg)
Closed: 9” (229mm)
Extended: 11.75“ (299mm)
3.25” (83mm)
1.5” (38mm)
Flow Rate Tubing
Length:
6” to 72” (152mm-1829mm)
Flow Rate Tubing / Residual Volume (ml)
F0.5
F1
F2
F3
F3.8
F5
F8
F10
F15
F30
F45
0.09
0.08
0.10
0.09
0.09
0.08
0.08
0.14
0.11
0.13
0.11
F60
F120
F180
F275
F420
F500
F600
F900
F1200
F2400
0.14
0.16
0.13
0.11
0.10
0.09
0.09
0.08
0.13
0.15
English 12 of 16
Warranty Information:
Limited Warranty:
RMS Medical Products/Repro Med Systems, Inc. (“Manufacturer”) warrants the
FreedomEdge™syringe infusion pump to be free from defects in materials and
workmanship under normal use. Warranty is limited to Original Purchaser and covers
the FreedomEdge™ for a period of two years from the purchase date. This warranty is
not valid for any damage caused by the use of non-RMS products. The “Original
Purchaser” is the person purchasing the infusion pump from the Manufacturer or
Manufacturer’s Representative. Warranty does not extend to subsequent purchasers.
Subject to the conditions of and upon compliance with the procedures set forth in this
limited warranty, the Manufacturer will repair or replace, at its option, any infusion
pump, or part thereof, which has been actually received by the Manufacturer or
Manufacturer’s Representative within the two-year warranty period, and which
examination discloses, to the Manufacturer’s satisfaction, that the product is defective.
Replacement product and parts are warranted only for the remaining portion of the
original two-year warranty period.
RMS rigorously tests the FreedomEdge™ using RMS accessories to ensure that the
FreedomEdge™ operates in accordance with published specification standards. If
non-RMS accessories are used in conjunction with the FreedomEdge™, RMS does not
represent that the FreedomEdge™ will operate in accordance with published
specification standards. The FreedomEdge™ warranty does not cover third-party
products or accessories.
The following conditions, procedures, and limitations apply to the Manufacturer’s
obligations under this warranty:
• Parties Covered by this Warranty: This warranty extends only to the
Original Purchaser of the infusion pump. This warranty does not extend to
subsequent purchasers.
• Warranty Performance Procedure: Notice of the defect must be made in
writing to Customer Support Department, RMS Medical Products/Repro-Med
Systems, Inc., 24 Carpenter Road, Chester, NY 10918, USA. Notice to RMS Medical
Products/Repro-Med Systems, Inc. must include the model and serial number, date
of purchase, and description of the defect in sufficient detail to facilitate repairs.
Authorization must be obtained by the Original Purchaser from the Manufacturer
or Manufacturer’s Representative prior to returning the product to the
Manufacturer. The defective pump must be properly packaged and returned to
the Manufacturer, postage-prepaid. Any loss or damage during shipment is at the
risk of the Original Purchaser.
• Conditions of Warranty: This warranty does not apply to any product, or part
thereof, which has been repaired or altered outside of the Manufacturer’s facility in
a way so as, in Manufacturer’s judgment, to affect its stability or reliability, or which
has been subjected to misuse, negligence or accident.
English 13 of 16
• Limitations and Exclusions: Repair or replacement of an infusion pump or
component part is the EXCLUSIVE remedy offered by the Manufacturer. The
following exclusions and limitations shall apply:
• No agent, representative, or employee of the Manufacturer has authority to
bind the Manufacturer to any representation or warranty, expressed or
implied, or to change this limited warranty in any way.
• THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THERE
ARE NO WARRANTIES THAT EXTEND BEYOND THE DESCRIPTION ON THE
FACE HEREOF.
• Manufacturer’s liability under this Limited Warranty Agreement shall not
extend to special, indirect, or consequential damages.
• The infusion pump can only be used under the supervision of medical
personnel whose skill and judgment determine the suitability of the
infusion pump for a particular medical treatment.
• All recommendations, information, and descriptive literature supplied by
the Manufacturer or its agents are believed to be accurate and reliable,
but do not constitute warranties.
This warranty and the rights and obligations hereunder, shall be construed under and
governed by the laws of the State of New York, USA.
English 14 of 16
Definition of symbols:
Caution
Quantity
Consult instructions for use
Catalog number
Authorized representative in the
European Community
Do not reuse
Use by YYYY-MM-DD or YYYY-MM
Serial number
Batch code
Sterilized using irradiation
Manufacturer
English 15 of 16
RMS Medical Products
24 Carpenter Road
Chester, NY 10918 USA
Ph. 800-624-9600 • 845-469-2042
www.rmsmedicalproducts.com
RMS Medical Products is ISO 13485 certified.
347200_Domestic_IFU_RevB